Hospitals knew a heart device led to more patients' deaths - but they kept using it

Both hospitals - the Freeman in Newcastle and Harefield in London - continued to use the pump for years, and questioned the reliability of the data flagged by the NHS. The pump's manufacturer, Medtronic, eventually withdrew it on safety grounds.

Patients with a weakened heart, who may be waiting for a transplant or deemed not suitable for one, can be offered a machine called an LVAD, a Left Ventricular Assist Device. It helps the heart pump blood around the body and, for many patients, this is their only chance of survival until a transplant becomes available.

The device is implanted into the heart, with an external wire coming out of the body - usually at the abdomen - that connects to a controller and external batteries.

LVADs have been life-savers for decades and, for a number of years, hospitals had a choice of two devices - the HeartWare HVAD, sold by the Irish-American company Medtronic, and the Heartmate III, sold by US manufacturer Abbott.

In October 2018, NHS Blood and Transplant (NHSBT), which oversees transplants in the UK, conducted a preliminary audit comparing how the two pumps had performed. A more detailed analysis followed in April 2019.

The results were stark. Of the 119 patients who had received the Medtronic device, 45% - or 54 patients - had died within two years. In contrast, just 15% - 15 out of 97 patients - who were given the Abbott pump had died over the same period. Similarly, the number of complications - such as strokes or needing a new pump - were significantly higher for the Medtronic device. The audit said there were "no significant differences" between the types of patients who received each device.

One of the UK's six transplant centres, the Royal Papworth Hospital in Cambridge, did not wait for the NHS analysis. It had picked up on the growing international concerns and had stopped using the Medtronic device in February 2018 "after considering the results of two randomised controlled trials", as their clinicians "considered the Heartmate III as superior".

However, Harefield Hospital continued to solely use the Medtronic device until early 2021, shortly after the manufacturer had issued a safety notice. The Freeman Hospital continued until June 2021, when the manufacturer withdrew it from sale "in the interest of patient safety".

The regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), continued to approve the device for use after the 2019 analysis, though it had not been informed by the NHS of the data's existence.

Throughout this time, patients fitted with the Medtronic device continued to die at a higher rate than those with the Abbott device.

Between October 2018, when the first set of NHS data was produced, and June 2021, when Medtronic discontinued its pump, the mortality rate of the Medtronic device was two-and-a-half times higher than the Abbott device, figures released under the Freedom of Information Act show.

Forty-nine percent of those who received the Medtronic device (39 of 80 patients) in that time died within three years. By comparison, 19% of recipients of the Abbott device (20 of 106 patients) died during the same timeframe.